FDA.reportPublic FDA data

Ketotifen Fumarate

Product NDC
0536-1252
11-digit product format
005361252
Labeler code
0536
Product ID
0536-1252_4d77465a-daa0-b622-e063-6294a90a7d81
Type
HUMAN OTC DRUG
Nonproprietary name
Ketotifen Fumarate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Rugby Laboratories
Application
NDA021996
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2020-09-18
Substance
KETOTIFEN FUMARATE
Active strength
.25 mg/mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ketotifen Fumarate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
KETOTIFEN FUMARATE.25 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHBD503WORO
Rxcui311237

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa9ae9d1-ed96-4d6e-8814-0a4815bc3229Product name120221208

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-1252-40Ketotifen Fumarate1 in 1 CARTONSOLUTION/ DROPS14
0536-1252-40Ketotifen Fumarate5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1252KETOTIFEN FUMARATE SOLUTION/ DROPS [RUGBY LABORATORIES]2Current NDC, Legacy NDC, 2 package rows20231215_8aa81ae9-112a-49fa-a0cb-ed0217a40de5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311237ketotifen 0.025 % Ophthalmic SolutionPSN8aa81ae9-112a-49fa-a0cb-ed0217a40de54
311237ketotifen 0.25 MG/ML Ophthalmic SolutionSCD8aa81ae9-112a-49fa-a0cb-ed0217a40de54
311237ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic SolutionSY8aa81ae9-112a-49fa-a0cb-ed0217a40de54
311237ketotifen 0.025 % Ophthalmic SolutionSY8aa81ae9-112a-49fa-a0cb-ed0217a40de54
311237ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic SolutionSY8aa81ae9-112a-49fa-a0cb-ed0217a40de54
311237ketotifen 0.025 % Ophthalmic SolutionPSN1234de19-257c-422c-8706-1239381a27061
311237ketotifen 0.25 MG/ML Ophthalmic SolutionSCD1234de19-257c-422c-8706-1239381a27061
311237ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic SolutionSY1234de19-257c-422c-8706-1239381a27061
311237ketotifen 0.025 % Ophthalmic SolutionSY1234de19-257c-422c-8706-1239381a27061
311237ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic SolutionSY1234de19-257c-422c-8706-1239381a27061

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0536-1252-40005361252401 BOTTLE, DROPPER in 1 CARTON (0536-1252-40) / 5 mL in 1 BOTTLE, DROPPER2020-09-180000-00-00NoNoCurrent